Galaxy UNYCO System— 510(k) K153233

Clearance details

Applicant

Orthofix Srl

Product code

Code KTT

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2015-11-09

Decision date

2016-01-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bussolengo, IT

• K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System2026-06-11
• K260900 — DYNEX® External Fixation Systems2026-04-17
• K260112 — QuikFix External Fixator: Knee-Spanning Pack2026-03-23
• K253291 — Excelsior System2026-01-20
• K253202 — Hoffmann LRF System2025-12-19

• K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM2026-05-19
• K253991 — Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA2026-05-08
• K250112 — FitboneTM Trochanteric2025-04-10
• K242270 — OrthoNext Platform System2024-12-19
• K242861 — TrueLok Elevate2024-12-03

Death

11

Injury

3,097

Malfunction

1,261

Total

4,369

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0291-2018 — Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.Class II·Terminated·Orthofix Srl·20170705

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153233.